Medical Plastic Data Service Magazine



Our 30th Year of Publication
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Global Market

Preparing For Global Markets: Basics of regulatory framework for Medical Devices

Mr. Amit Dave,
M. Pharm, MBA,
Former CEO - Brazil Operations/ Vice President Export – Zydus Cadila/Claris Lifesciences

Regulatory strategy for an organization

From Regulatory point of view, Covid pandemic has brought high awareness about quality aspects of devices, mainly the devices used for Covid but also, all other MDs in general. Along with awareness, connections and coordination amongst Regulatory authorities of various countries have also increased, again, primarily for Covid related developments but the same coordination is helping them exchange more information.

As mentioned earlier, in Regulatory scenario of the countries of the world, there are two extremes. On one side, least restrictions while on the other side, there are stringent regulations. The World Health Organization (WHO) is trying to achieve a harmonized system, but this harmonization is going to be achieved over a very long-term. Though this harmonization plan looks easily implementable immediately, it will not be implemented soon. These country-wise differences, therefore, will remain a challenge for the exporters. In the future articles, we will discuss these differences also.


For an organization, developing a Regulatory program needs vision of the management, resources, and manpower. Implementation of such a program is painful mainly because the resources needed are immediate while results will be visible and bear fruits after months or years. Sometimes developing a Regulatory framework may challenge the existing norms of manufacturing and systems and no organization would like this. The experience of this author is, however, that once the basic framework is achieved, to expand further on that base is not difficult.


QRS Model - Broad Regulatory Framework


Our readers would certainly be familiar with the new norms prescribed in India for Medical Devices Registration. We will discuss overseas regulations from that starting point of Indian norms. As seen earlier, Device Regulations have been defined as measures that governments take to ensure the safety, efficacy, and quality of the medical products, including relevance and accuracy of product information.


The standard model for Regulatory framework of almost all the countries in the world follow a model called QRS Model. Here-


Q denotes Quality
R represents Risk, and
S mentions systems


…pertaining to a specific product / product bundle.


QRS model is followed by Product specific norms and Handling norms. The total model is thus denoted by QRS + HP system.


Let us understand this basic model in more detail. Since the products in Medical Devices category have wide and wild variations in them, in this article we will still understand the broader outline. Soon we will approach specifics in the coming articles, for sure.


Q denotes Quality


Initially quality was defined as “fitness for use” but now a broad definition is “activities designed to maintain a desired level of excellence” for a product. The word Quality has graduated where now, the ultimate test is excellence, not mere usage. A product will have to be fit for usage purpose and should tend to be an excellent product for its purpose. And who will know the quality standards for a product better other than you, its manufacturer or a marketeer? A manufacturer will know how to test the quality standards as well as possible gaps and how to ensure that those gaps do not affect product’s expected ultimate usage. In the forthcoming articles, the basic parameters for Quality will be expanded and connected with regulatory norms for specific countries.


R represents Risk


Risk management for medical devices is well covered in the Definition of ISO 14971. All products and processes do have risks and risks cannot become zero, though ideally it should be that way. In the sum, Benefits of a product must outweigh Risk, and for that assessment, the manufacturer should assess Risk of his products. This ISO 14971 gives guidance for risk identification, analysis, evaluation as well as control and management for reducing risk. Not only that, procedures during and after production for risk management are also explained. Risk has two components – Degree and Possible Frequency, and these components become product and process specific.


S for Systems


A product is a final output result of sum of all the inputs. These inputs include product specific inputs like components, ingredients, etc and human efforts as well as processes being followed. Each input may have sub-inputs. How is a component procured, stored, checked, and processed for making the final product? This is the broad framework of process. Production control and process control are the basics of the system control. After understanding this broad frame, we will aim for specifics in the next articles.

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